MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSIST) BYPASS

Model Number 106524US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemolysis (1886); Stenosis (2263); Hemorrhagic Stroke (4417); Ischemia Stroke (4418); Lactate Dehydrogenase Increased (4567)

Event Date 06/24/2022

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that the patient suffered an ischemic stroke with hemorrhagic conversion that was diagnosed on (b)(6) 2022.The patient had an altered mental status post-stroke with stable serial head computed tomography (ct) scans.It was noted that the patient had worsening neurological status.The patient's anticoagulation was held.They were closely monitored in the intensive care unit (icu).They had an overnight increase in aspartate aminotransferase (ast), alanine aminotransferase (alt), and lactate dehydrogenase (ldh).There were no changes to pump parameters.There was evidence of hemolysis but pump thrombus was ruled out.Once the ct scans were stable, the patient was restarted on heparin drip and then coumadin (warfarin) per neurology's recommendation.It was noted that the patient had 70% stenosis of their left internal carotid artery that would be addressed in the future.The patient remained hospitalized in the intermediate care unit (imc).The patient was non-verbal.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported event could not conclusively be established through this evaluation.The submitted system controller event log file contained data from (b)(6) 2022 through (b)(6) 2022.The file was unremarkable and the pump appeared to operate as intended at the set speed.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6).No further related events have been reported at this time.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 01jun2022.The heartmate 3 lvas instruction for use (ifu), rev.C, is currently available.Section 1 of this document lists stroke, bleeding, hemolysis, and other neurological events as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 1 provides an explanation of all pump parameters.Section 6 entitled ¿patient care and management¿ also lists neurological dysfunction as a potential late postimplant complication.Section 6 ¿patient care and management¿ (under "anticoagulation") also outlines the recommended anticoagulation regimen (including international normalized ratio (inr) range) for patients using the heartmate 3 lvas as well as the suggested anticoagulation modifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15114835
• MDR Text Key: 296714814
• Report Number: 2916596-2022-12165
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/18/2024
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8485092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2022
• Initial Date FDA Received: 07/27/2022
• Supplement Dates Manufacturer Received: 10/25/2022
• Supplement Dates FDA Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White